Ignite Creation Date:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2025-12-25 @ 11:09 PM
Study NCT ID:
NCT07275567
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-10
First Post:
2025-11-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Data-driven Development of a Core Dataset for Difficult Airway Alerts
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1785}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-27', 'studyFirstSubmitDate': '2025-11-27', 'studyFirstSubmitQcDate': '2025-11-27', 'lastUpdatePostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difficult airway alert', 'timeFrame': '1 hour', 'description': 'Documented by the airway operator following tracheal intubation (y/n)'}], 'secondaryOutcomes': [{'measure': 'Recommendation for awake tracheal intubation', 'timeFrame': '1 hour', 'description': 'Recommendation for future airway planning documented by the airway operator after tracheal intubation (y/n)'}, {'measure': 'Recommendation for camera-assisted tracheal intubation', 'timeFrame': '1 hour', 'description': 'Recommendation for future airway planning documented by the airway operator after tracheal intubation (y/n)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Difficult airway alerts', 'Airway alert cards', 'Airway documentation', 'Electronic health records'], 'conditions': ['Airway Management', 'Intubation; Difficult or Failed', 'Airway Complication of Anesthesia']}, 'referencesModule': {'references': [{'pmid': '36006056', 'type': 'RESULT', 'citation': 'Kohse EK, Siebert HK, Sasu PB, Loock K, Dohrmann T, Breitfeld P, Barclay-Steuart A, Stark M, Sehner S, Zollner C, Petzoldt M. A model to predict difficult airway alerts after videolaryngoscopy in adults with anticipated difficult airways - the VIDIAC score. Anaesthesia. 2022 Oct;77(10):1089-1096. doi: 10.1111/anae.15841. Epub 2022 Aug 25.'}, {'pmid': '38789407', 'type': 'RESULT', 'citation': 'Kohl V, Wunsch VA, Muller MC, Sasu PB, Dohrmann T, Peters T, Tolkmitt J, Dankert A, Krause L, Zollner C, Petzoldt M. Hyperangulated vs. Macintosh videolaryngoscopy in adults with anticipated difficult airway management: a randomised controlled trial. Anaesthesia. 2024 Sep;79(9):957-966. doi: 10.1111/anae.16326. Epub 2024 May 24.'}, {'pmid': '40310618', 'type': 'RESULT', 'citation': 'Popal Z, Sieg HH, Muller-Wiegand L, Breitfeld P, Dankert A, Sasu PB, Wunsch VA, Krause L, Zollner C, Petzoldt M. Decision-Making Tool for Planning Camera-Assisted and Awake Intubation in Head and Neck Surgery. JAMA Otolaryngol Head Neck Surg. 2025 Jun 1;151(6):585-594. doi: 10.1001/jamaoto.2025.0538.'}]}, 'descriptionModule': {'briefSummary': 'Previous difficult airway management is the most accurate predictor of future difficulty. Consistent documentation is paramount for future airway planning, but requires reliable, reproducible and easily accessible information. Currently, anaesthesia alert cards are often based on analogue hard copies while they lack a clinically meaningful core data set allowing structured reproducible documentation and risk estimation. Further, existing alert cards are often inconsistently used and clear triggers for issuing of airway alert cards are widely undefined. The FingAIRprint project aims to develop a justifiable core data set using a data-driven approach in patients undergoing tracheal intubation with videolaryngoscopy or direct laryngoscopy, that is intended to be used for documentation of digital airway alerts.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Pooled database from three prospective studies originating from a single study center in adults undergoing elective head and neck surgery with general anaesthesia and tracheal intubation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing general anesthesia with tracheal intubation\n* Informed consent obtained\n* Age \\> 18 years\n\nExclusion Criteria:\n\n* Indication for intubation via a bronchoscope or awake intubation\n* Pregnant women'}, 'identificationModule': {'nctId': 'NCT07275567', 'acronym': 'FingAIRprint', 'briefTitle': 'Data-driven Development of a Core Dataset for Difficult Airway Alerts', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsklinikum Hamburg-Eppendorf'}, 'officialTitle': 'Data-driven Development of a Core Dataset for Documentation of Difficult Airway Alerts - a Secondary Analysis of Pooled Database From Three Prospective Studies - the FingAIRprint Project', 'orgStudyIdInfo': {'id': '2024-300503-WF'}}, 'contactsLocationsModule': {'locations': [{'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Department of Anesthesiology, Center for Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsklinikum Hamburg-Eppendorf', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}